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Abstract

BACKGROUND The Effect of Lipid Modification on Peripheral Arterial Disease after Endovascular Intervention Trial (ELIMIT), a prospective double-blind randomized study, was designed to determine over 24-months, the effects of triple drug lipid modification therapy versus mono therapy on the progression of atherosclerotic lesions in the distal superficial femoral artery (SFA), as assessed by 3.0T magnetic resonance imaging (MRI).

METHODS A total of 95 patients were randomized to either mono therapy with simvastatin (40mg) or triple therapy with simvastatin (40mg), extended-release niacin (1.5g), and ezetimibe (10mg). MR imaging was performed at baseline, 6-, 12-, and 24-months. SFA wall, lumen, and total vessel volumes were quantified using inter-visit co-registered proton-density-weighted turbo spin echo MRI sequences. MRI derived SFA parameters and lipids were analyzed with multi-level models and non-parametric tests, respectively.

RESULTS Baseline characteristics did not differ between mono and triple therapy groups, except for ethnicity (Table). There was no difference in adverse cardiovascular events between groups (p=0.99). SFA wall, lumen, and vessel volumes increased non-significantly for both groups between baseline and 24-months. Non-high-density lipoprotein cholesterol showed a larger reduction in triple therapy compared with mono therapy at 12-months (p=0.01).

CONCLUSION Despite improved atherogenic lipid profiles, there was no significant difference between mono therapy with simvastatin and triple therapy with simvastatin, extended-release niacin, and ezetimibe for the 24-month changes in total SFA wall, lumen, and vessel volumes.